Basic Trial Information

Phase

Type

Status

Age

Trial IDs

Phase III

Supportive care

Active

18 and over

2009-0976NCI-2012-01895, NCT01202851

Trial Description

Summary

This randomized phase III trial studies yoga or stretching and relaxation in improving physical function in patients with stage 0-III breast cancer undergoing radiation therapy. Yoga therapy may help improve quality of life in breast cancer patients undergoing radiotherapy. It is not yet known if yoga is more effective than stretching and relaxation in improving physical function.

Further Study Information

PRIMARY OBJECTIVES:

I. Examine the efficacy of a yoga program incorporated into the treatment schedule for women with breast cancer undergoing radiotherapy.

II. Determine the effects of the yoga program on other aspects of adjustment.

III. Identify some of the processes underlying the efficacy of the intervention.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients attend 60-minute yoga classes 3 times per week for 6 weeks or 4-5 times per week for 4 weeks, concurrently with radiation therapy. Patients are then further randomized to maintenance comprising telephone contact once per month with booster sessions every 3 months after completion of therapy, or usual care, with no contact after completion of therapy.

ARM II: Patients attend 60-minute stretching and relaxation classes 3 times per week for 6 weeks or 4-5 times per week for 4 weeks, concurrently with radiation therapy. Patients are then further randomized to maintenance or usual care as in Arm I.

ARM III: Patients complete quality of life assessments.

After completion of study treatment, patients in the maintenance arms are followed up monthly, and patients in usual contact arms and in arm III are followed up at 3, 6, and 12 months.

Trial Sites

U.S.A.

Texas

Houston

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Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.